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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.
 
Trade NameARGUS II RETINAL PROSTHESIS SYSTEM
Classification Nameprosthesis, retinal
Generic Nameprosthesis, retinal
Applicant
SECOND SIGHT, LLC.
12744 san fernando rd.
building 3
sylmar, CA 91342
HDE NumberH110002
Supplement NumberS021
Date Received08/21/2015
Decision Date09/14/2015
Product Code
NBF[ Registered Establishments with NBF ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Update to the implant sterilization procedure to allow exposure to a second ethylene oxide (eo) cycle, vendor qualification for supplying the niobium wall and lidcomponents of the implant and for adopting a revised method to verify hermeticity of the implant.
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